Ethical and moral points of view

1.  We regret that the Department of Health did not seek to specify more clearly in its consultation what views it was seeking, nor to evaluate fully the responses of the public consultation exercise. We recommend that in future a more systematic statistical or scientific approach is developed to quantify and qualify the results of public consultation. (Paragraph 41)

2.  We recognise the sincere ethical and moral concerns associated with research of this nature and are therefore concerned that, to respond to these concerns, any regulatory framework associated with use of human-animal chimera or hybrid embryos in research should be transparent and workable. (Paragraph 42)

3.  We are of the opinion that ethical and moral concerns should be considered within the context in which they are made, and that inappropriate use of science to justify ethical and moral arguments is unhelpful. Inappropriate use of science should be identified and disregarded by Government and other policy-makers. (Paragraph 43)

4.  In line with the recommendation of the previous Science and Technology Committee, we recommend the creation of a new Parliamentary standing Committee on Bioethics. (Paragraph 44)

Potential problems with this research

5.  In the event that research using cytoplasmic hybrid embryos is authorised, we urge the Government to ensure that appropriate risk management procedures are established and implemented (Paragraph 54)

6.  Research, by its very nature, is aimed at enhancing knowledge. Whilst we recognise scientific debate about the potential usefulness of cytoplasmic hybrid embryos in research, we do not believe that the existence of differing views of whether a methodology is workable before it has been sufficiently tested is reason enough to prohibit such research from taking place. (Paragraph 57)

Scientific opposition to research involving hybrid and chimera embryos

7.  We recognise the scientific debate among experts about the potential usefulness of the research under discussion in this Report but we conclude that the scientific community as a whole is supportive of the work being licensable, even where there may be doubts about its likely success. (Paragraph 58)

Conclusions on the desirability and necessity of hybrid and chimera embryo research

8.  We believe that the creation of human-animal chimera or hybrid embryos, and specifically cytoplasmic hybrid embryos, is necessary, for example in the pursuit of knowledge about the genetic basis of disease and the direction of stem cells into future cell-based therapy. Furthermore, we recognise that stem cells produced through this methodology may be useful in drug discovery and that they may lead to the eventual reduction of animal use, for example in toxicity testing. (Paragraph 59)

9.  We believe that use of animal eggs in the creation of cytoplasmic hybrid embryos will help to overcome the current shortage of human eggs available for research and that use of animal eggs is required to enable researchers to develop the practical techniques which may be required for eventual production of cell-based therapy through this method using human eggs. (Paragraph 60)

The role of the HFEA in regulating research

10.  We agree with HFEA that the wider issue of whether human-animal chimera or hybrid embryos should be allowed for research should be decided by Parliament. However, it is the role of HFEA to make judgements in areas considered within the spirit of the HFE Act where its legal advice indicates that it is reasonable to do so. Not to do so undermines the effectiveness of an independent regulator. (Paragraph 64)

11.  We support the decisions of the HFEA Science and Clinical Advances Group, Ethics and Law Committee and Horizon Scanning Group that an embryo containing human nuclear DNA and mitochondria of animal origin should be regarded as a human embryo for the purposes of the 1990 HFE Act. (Paragraph 68)

12.  We understand that some form of viability test will have been subject to the legal advice sought by the HFEA on this issue. Nevertheless, we have grave scientific concerns about its validity. We do not believe that it is appropriate to use viability as a mechanism for determining whether or not a creation is human, particularly since attempts to prove viability through implantation in a uterus would be unlawful. Furthermore, were the viability test to be failed, this would mean that such research would be completely unregulated, which case law has found to be unsatisfactory. (Paragraph 71)

13.  We support the decision of the HFEA that research involving the creation of cytoplasmic hybrid embryos would probably fall with the remit of the HFEA to regulate and license and would not be prohibited by current legislation. Although we have received submissions from those who do not believe that this is the case, the weight of scientific and legal argument is in favour of treating these embryos as human. We accept that this decision might leave the HFEA open to legal challenge that it was acting ultra vires in considering the applications. However, given the accepted desirability for legal clarification in this area, we view legal challenge as highly likely but also potentially helpful in establishing the limits of the HFEA's remit. (Paragraph 72)

14.  It would have aided transparency and public and parliamentary debate on this subject if the HFEA's legal advice had been published. (Paragraph 75)

15.  We view public consultation in this area as valuable. However, we are of the opinion that this exercise should have been undertaken when the HFEA first received information to indicate that applications for licensing the creation of human-animal chimera or hybrid embryos could be expected. (Paragraph 76)

Delay in assessment of the applications

16.  While we agree with the HFEA that the general issues of hybrid and chimera embryos should be dealt with by Parliament, we consider that it is the role of the HFEA to deal with the applications for the creation of cytoplasmic hybrid embryos under current legislation with due speed and process. (Paragraph 77)

The parliamentary process

17.  We agree that there is a need for revised legislation, decided by Parliament, to regulate for current developments in the creation of human-animal hybrid and chimera embryos and to provide a future framework under which regulatory authorities can operate. (Paragraph 78)

18.  We support the Government's intention for pre-legislative scrutiny of the draft Bill and encourage the Government to take advantage of all possible sources, including this Report and that of our predecessor Committee, to inform the debate. (Paragraph 79)

Definitions and terminology in the draft Bill

19.  We are critical of the Government for not clearly setting out areas of research practice intended to fall under the proposed legislation. Much confusion has thus been caused. However, we accept that this lack of clarity may result from the lack of understanding more generally with regard to the potential for this area of research and what the term 'human-animal chimera or hybrid embryos' may cover. We welcome moves by the Academy of Medical Sciences to address this problem and we urge the Government to work with the Academy, HFEA and other stakeholders to ensure that the scope of research practice intended to be covered by legislation is clearly defined in the draft Bill. (Paragraph 85)

The proposed prohibition

20.  We find the Government proposals in the White Paper unnecessarily prohibitive and recommend the Government ensure that its draft Bill reflects the liberal view it claims to be taking in opening the door to research using human-animal chimera or hybrid embryos. (Paragraph 88)

21.   We believe that there is a need to allow research using some forms of human-animal chimera or hybrid embryos, including but not exclusively cytoplasmic hybrid embryos, to proceed immediately. We recommend that the Government propose draft legislation which is immediately permissive, through regulation, to those areas of research it deems acceptable. (Paragraph 90)

Drawing the line: acceptable research practice

22.  We believe that, in general, the creation of all types of human-animal chimera or hybrid embryos should be allowed for research purposes, if appropriately regulated. However, in line with the recommendation of the previous Committee, we see no benefit from allowing the development of human-animal chimera or hybrid embryos past the 14-day stage in vitro and recommend that such practice is not licensed unless it is proved necessary. (Paragraph 93)

23.  In line with the recommendations of the previous Science and Technology Committee, we recommend that legislation prohibit the implantation of human-animal chimera or hybrid embryos in a woman. (Paragraph 94)

24.  We recommend that care be taken by the Government to ensure that the draft Bill does not prohibit research using human embryonic stem cell lines where such research is currently regulated through the Animals (Scientific Procedures) Act 1986. (Paragraph 96)

25.  We recommend that legislation allow for regulation of the implantation of human stem cells, whether created from human embryos or human-animal chimera or hybrid embryos, into animal blastocysts. (Paragraph 98)

Legislative and regulatory structure

26.  We have made it clear that we regard the current Government proposals as overly prohibitive and that there should be regulation of this research area through licensing. The new legislative structure should permit the creation of animal-human hybrid and chimera embryos for research purposes, subject to regulation, and should aim to reduce the risk of litigation on borderline cases. (Paragraph 99)

27.  We recommend that the Government proposals in the Bill for the regulation of the creation of animal-human chimera and hybrid embryos be based on the legislative structures outlined in paragraph 100 of this Report. (Paragraph 102)

Impact of the legislative structure on UK science

28.  A ban and the prospect of a ban in draft legislation on human-animal chimera or hybrid embryos would undermine the UK's leading position in stem cell research and the international reputation of science in the UK. (Paragraph 104)

29.  We are concerned that a ban or a proposed ban may not only encourage researchers to leave the UK in order to undertake their research in a more permissive regulatory regime, but it may also inhibit early stage researchers entering the field. Whilst we do not believe that UK competitiveness should dictate policy in a research area, we believe that the Government should consider this as a contributory factor and we recommend that the Government ensure that it is properly briefed on potential implications from future legislation in this area. (Paragraph 107)

Public confidence

30.  Public awareness of the need for and benefits of research in this area should be encouraged, alongside an understanding of the reasons for the requirement to update legislation. We regard it as the responsibility of the Government and HFEA to keep the public informed in respect of developments in legislation related to the creation of human-animal chimera and hybrid embryos for research. (Paragraph 108)

31.  We take criticisms of the Government's consultation seriously and we recommend that they be taken into consideration both in relation to the proposals for revised legislation in this area and in future consultation exercises. (Paragraph 111)

32.  We find it unhelpful that witnesses on both sides of the argument have claimed to represent the public view, where supporting evidence for this is lacking. (Paragraph 113)

Public understanding

33.  Accomplishing effective public engagement in this debate may be difficult, but significant effort must be made to this end. We believe that additional education is required to enhance public understanding of the techniques proposed by this area of research and its associated potential achievements and problems, including scientific, ethical and moral concerns. (Paragraph 114)

34.  Notwithstanding the accompanying delay in consideration of the King's College London and Newcastle University research applications, we welcome the HFEA proposed consultation on general principles and commend steps taken by the Authority to ensure appropriate drafting. We also commend the Government for allowing funding to be allocated toward education in this area. (Paragraph 115)